Exploring access to HIV-related services and programmatic gaps for Men having Sex with Men (MSM) in rural India- a qualitative study.

BACKGROUND: Despite the Link Worker Scheme to address the HIV risk and vulnerabilities in rural areas, reaching out to unreached men having sex with men (MSM) remains a challenge in rural India. This study explored issues around health care access and programmatic gaps among MSM in rural settings of India. METHODS: We conducted eight Focused Group Discussions (FGDs), 20 Key Informant Interviews (KIIs), and 20 In-Depth Interviews (IDIs) in four rural sites in Maharashtra, Odisha, Madhya Pradesh, and Uttar Pradesh between November 2018 and September 2019. The data in the local language were audio-recorded, transcribed, and translated. Data were analyzed in NVivo version 11.0 software using the grounded theory approach. RESULTS: Primary barriers to health care access were lack of knowledge, myths and misconceptions, not having faith in the quality of services, program invisibility in a rural setting, and anticipated stigma at government health facilities. Government-targeted intervention services did not seem to be optimally advertised in rural areas as MSM showed a lack of information about it. Those who knew reported not accessing the available government facilities due to lack of ambient services, fear of the stigma transforming into fear of breach of confidentiality. One MSM from Odisha expressed, "…they get fear to go to the hospital because they know that hospital will not maintain confidentiality because they are local people. If society will know about them, then family life will be disturbed" [OR-R-KI-04]. Participants expressed the desire for services similar to those provided by the Accredited Social Health Activists (ASHA), frontline health workers for MSM. CONCLUSION: Programme invisibility emerges as the most critical issue for rural and young MSM. Adolescent and panthis emerged as Hidden MSM and they need focused attention from the programme. The need for village-level workers such as ASHA specifically for the MSM population emerged. MSM-friendly health clinics would help to improve healthcare access in rural MSMs under Sexual and Reproductive Health Care.

Emotional distress among adolescents living with perinatal HIV in India: examining predictors and their mediating and moderating effects.

BACKGROUND: Development of emotional distress (ED) among adolescents living with perinatally acquired HIV (ALPHIV) affects their adherence behaviour and social and psychological functioning. Data on stressors among ALPHIV demonstrates the gap on the predictors of ED experienced by 'perinatally infected ALHIV' in the Indian socio-cultural milieu. This study aimed to identify the predictors of ED and examine their mediating and moderating role in the development of ED among Indian ALPHIV. METHODS: Utilizing the sequential exploratory mixed-methods design, 43 qualitative interviews were conducted with ALPHIV, parents/guardians, and health care providers, followed by the cross-sectional survey among 100 ALPHIV (10-19 years). The distress subscale of the Weinberger Adjustment Inventory was used to measure ED. Qualitative data, analyzed using grounded theory were utilized to develop a survey tool. Bivariate and regression analyses were conducted to identify predictors of ED. Mediation and moderation models were tested to examine underlying mechanisms associated with ED. The study was approved by the institutional ethics committee. RESULTS: Strong parental control, compulsive asexuality, perceived negatively different from peers, and anger toward parents were the major themes emerging from the qualitative component which eventually led to survey tool domains viz., HIV awareness, parental control, hypervigilance, adolescent-parent relationship, adolescent-parent communication, body image and perceived negatively different from peers (PNDP). Quantitative analysis indicated high ED among ALPHIV and ED was significantly associated with PNDP, anger, body image, and hypervigilance. The relationship between PNDP and ED was significantly mediated by anger, and moderated by body image and hypervigilance. CONCLUSIONS: The study stresses the need for early mental health interventions for Indian ALPHIV before an ALPHIV develops ED. Focused counseling on anger assessment, body image issues, and self-perception is critical for leading a 'normal' life by ALPHIV. Besides, skill building of primary caregivers is recommended to draw a line between protection and overprotection.

Prevention of recurrence of bacterial vaginosis using lactobacilli-containing vaginal tablets among women with HIV: a randomized, placebo-controlled, double-blinded phase IV trial.

OBJECTIVES: The effectiveness of lactobacilli-containing vaginal tablets (VT) in bacterial vaginosis (BV) recurrence prevention among women infected with HIV treated with standard oral metronidazole in Pune, India was studied. METHODS: Women infected with HIV with confirmed BV diagnosis (Nugent score ≥7 and Amsel criteria >3) were enrolled in a 12-month, double-blind, randomized, placebo-controlled, phase IV study between 2018 and 2021. After a standard course of oral metronidazole for 7 days (400 mg three times a day), women were randomly assigned to either lactobacilli-containing or placebo VT arms to receive VTs for 4 months. BV recurrence was assessed after the initial cure from BV. RESULTS: Of the 464 women infected with HIV, 80 women with confirmed BV were enrolled. The retention was affected due to the COVID-19 pandemic (6-month retention rates 78%). The cure was seen in 85% and 93.5% of participants from the treatment and placebo arms, respectively, after four VT cycles. BV recurrence was seen in 41.4% and 44.8% in the treatment and placebo arm, respectively, with no significant difference in the two groups. CONCLUSION: The lactobacilli-containing VT was acceptable and safe; however, the addition of VT over standard oral metronidazole did not show any additional benefit in the prevention of BV recurrence in women infected with HIV, indicating the need for long-term randomized trials among them. Registered at Clinical Trials Registry- India, (CTRI) Number: CTRI/2018/04/013298.

A Couples-Based Intervention (Ghya Bharari Ekatra) for the Primary Prevention of Intimate Partner Violence in India: Pilot Feasibility and Acceptability Study.

BACKGROUND: The high global prevalence of intimate partner violence (IPV) and its association with poor physical and mental health underscore the need for effective primary prevention. We previously developed Ghya Bharari Ekatra (GBE), a couples-based primary prevention intervention for IPV among newly married couples residing in slum communities in Pune, India. OBJECTIVE: Through this pilot study, we aimed to explore the acceptance, safety, feasibility, and preliminary efficacy of GBE. METHODS: Between January and May 2018, we enrolled and assigned 20 couples to receive GBE plus information on IPV support services and 20 control couples to receive information on IPV support services alone. The GBE intervention was delivered over 6 weekly sessions to groups of 3 to 5 couples by lay peer educators in the communities in which the participants resided. Intervention components addressed relationship quality, resilience, communication and conflict negotiation, self-esteem, sexual communication and sexual health knowledge, and norms around IPV. Outcome evaluation included exit interviews with participants and peers to examine acceptance and feasibility challenges and baseline and 3-month follow-up interviews to examine change in IPV reporting and mental health (by women) and alcohol misuse (by men). The process evaluation examined dose delivered, dose received, fidelity, recruitment, participation rate, and context. RESULTS: Half (40/83) of the eligible couples approached agreed to participate in the GBE intervention. Retention rates were high (17/20, 85% across all 6 sessions), feedback from exit interviews suggested the content and delivery methods were very well received, and the community was highly supportive of the intervention. The principal feasibility challenge involved recruiting men with the lowest income who were dependent on daily wages. No safety concerns were reported by female participants over the course of the intervention or at the 3-month follow-up. There were no reported physical or sexual IPV events in either group, but there were fewer incidents of psychological abuse in GBE participants (3/17, 18%) versus control participants (4/16, 25%) at 3-month follow-up. There was also significant improvement in the overall mental health of female intervention participants and declines in the control participants (change in mean General Health Questionnaire-12 score: -0.13 in intervention vs 0.13 in controls; P=.10). CONCLUSIONS: GBE has high acceptance, feasibility, and preliminary efficacy in preventing IPV and improving mental health among women. Next steps include refining the intervention content based on pilot findings and examining intervention efficacy through a large-scale randomized trial with longer follow-up. TRIAL REGISTRATION: ClinicalTrials.gov NCT03332134; https://clinicaltrials.gov/ct2/show/NCT03332134. Clinical Trials Registry of India CTRI/2018/01/011596; http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=21443. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11533.

A Qualitative Exploration to Understand the Sexual Behavior and Needs of Young Adults: A Study Among College Students of Pune, India.

OBJECTIVE: Youth and adolescents are the priority population to target the interventions as risky behaviors persist and they contribute to almost half of the new Human immunodeficiency virus (HIV) infections. The youth in India have a unique and diverse need of sex health education. The present study was conducted with the objective to understand their sexual behavior and requirements of sexual health. METHODS: Focus group discussions were conducted among 74 college students, separately for boys and girls. The participant students were from different streams of education. The domains of enquiry were related to the relationships, risk behaviors, sources of information and use of technology for sex health education. The qualitative data was analyzed based on the themes and subthemes derived from these discussions. RESULTS: A majority of the youth favoured active involvement of parents, school teachers in sex health education. They suggested that better-informed parents lead to better-informed adolescents. Open discussion with experts was also desired by the students. The use of mobile/web based application for sex health education and awareness about HIV and sexually transmitted infections (STIs) was preferred, however, they suggested that based on personal requirements, individual need based counseling and guidance is important. CONCLUSIONS: Active parental involvement and open discussions on sexuality were the preferred options by the student to seek the knowledge and guidance. Innovative mobile application for sex health education will be useful for the young adults for information and communication. The study highlighted a need to develop a holistic approach to generate a culturally-sensitive sex health education and life skills model.

Incomplete functional T-cell reconstitution in immunological non-responders at one year after initiation of antiretroviral therapy possibly predisposes them to infectious diseases.

BACKGROUND: Immunological non-responders (INR) represent a unique category of HIV-infected patients on antiretroviral therapy. These patients have suppressed viremia but a suboptimal increase in CD4 cell count, which might have opposing effects on functional immune reconstitution. Hence, the extent of immune reconstitution in INR patients was investigated in order to determine their susceptibility to opportunistic infections. METHODS: Twenty-three INR patients (CD4 increase <50 cells/mm3, viral load <40 copies/ml), 40 age-, sex-, and baseline CD4 count-matched responders (CD4 increase >100 cells/mm3, viral load <40 copies/ml), and 18 treatment failures defined as per the national guidelines were enrolled at 1year of antiretroviral therapy. The following examinations were performed: haemogram, phenotypic characterization by flow cytometry, and assessment of functional immune status by ELISPOT and intracellular cytokine assays. RESULTS: A higher percentage of INR patients had clinically symptomatic infections than the responders. CD8+ activation and innate immune parameters, including the absolute neutrophil count and natural killer (NK) cell frequency and functionality, were restored in the INR patients. They had significantly higher non-HIV antigen-specific T-cell responses and activated CD4+ cells, but significantly compromised T-cell functionality, as assessed after anti-CD3 stimulation, and lower CD31+ and CD62L+CD4+ cells. CONCLUSIONS: INR patients showed lower thymic output, incomplete functional T-cell reconstitution, higher responses to HIV co-pathogens, and higher symptomatic events, indicating the need for close monitoring and intervention strategies to overcome their continuing immunocompromised status.

GeneXpert HIV-1 quant assay, a new tool for scale up of viral load monitoring in the success of ART programme in India.

BACKGROUND: Recent WHO guidelines identify virologic monitoring for diagnosing and confirming ART failure. In view of this, validation and scale up of point of care viral load technologies is essential in resource limited settings. METHODS: A systematic validation of the GeneXpert® HIV-1 Quant assay (a point-of-care technology) in view of scaling up HIV-1 viral load in India to monitor the success of national ART programme was carried out. Two hundred nineteen plasma specimens falling in nine viral load ranges (<40 to >5 L copies/ml) were tested by the Abbott m2000rt Real Time and GeneXpert HIV-1 Quant assays. Additionally, 20 seronegative; 16 stored specimens and 10 spiked controls were also tested. Statistical analysis was done using Stata/IC and sensitivity, specificity, PPV, NPV and %misclassification rates were calculated as per DHSs/AISs, WHO, NACO cut-offs for virological failure. RESULTS: The GeneXpert assay compared well with the Abbott assay with a higher sensitivity (97%), specificity (97-100%) and concordance (91.32%). The correlation between two assays (r = 0.886) was statistically significant (p < 0.01), the linear regression showed a moderate fit (R2 = 0.784) and differences were within limits of agreement. Reproducibility showed an average variation of 4.15 and 3.52% while Lower limit of detection (LLD) and Upper limit of detection (ULD) were 42 and 1,740,000 copies/ml respectively. The misclassification rates for three viral load cut offs were not statistically different (p = 0.736). All seronegative samples were negative and viral loads of the stored samples showed a good fit (R2 = 0.896 to 0.982). CONCLUSION: The viral load results of GeneXpert HIV-1 Quant assay compared well with Abbott HIV-1 m2000 Real Time PCR; suggesting its use as a Point of care assay for viral load estimation in resource limited settings. Its ease of performance and rapidity will aid in timely diagnosis of ART failures, integrated HIV-TB management and will facilitate the UNAIDS 90-90-90 target.

Cognitive Function among HIV Infected Children in Pune.

OBJECTIVE: To assess cognitive function of school-aged, perinatally acquired human immunodeficiency virus (HIV)-infected, antiretroviral therapy (ART) naïve children in Pune. METHODS: HIV infected ART naïve children (n = 50) between 6 and 12 y attending outpatient clinic were administered the Indian Child Intelligence Test (ICIT) after their clinical evaluation. Age and gender matched HIV uninfected children (n = 50) were enrolled as controls. The test battery included measures of perception of form (Gestalt), concept formation, memory span, learning and remembering, associative memory span, transformation of visual field, quantitative concepts, spatial visualization and visual motor coordination. The information on adaptive behavior was obtained from the care giver and a brief interview with the child using Vineland Social Maturity Scale (VSMS). RESULTS: Mean age of the children was 9.3 y (SD: 1.3) and mean education was 4.3 y (SD: 1.3). The mean CD4 count of HIV infected children was 588 cells/mm(3) (SD: 324.4). There was no significant difference in the overall ICIT scores between HIV infected and uninfected children (p 0.209). The adaptive behavior (VSMS) scores were significantly less in HIV infected children as compared to others (p 0.028). CONCLUSIONS: There was no significant difference in the overall cognitive abilities in HIV infected children using ICIT as compared to HIV uninfected children, although significant difference in the adaptive behavior between the two groups was observed. It is important to conduct larger prospective studies using standardized test batteries that are inclusive of multiple cognitive domains sensitive to HIV effects in Indian children.

HIV drug-resistance early-warning indicators and quality care in India: preliminary findings from a pilot study in Pune city.

BACKGROUND: India has rapidly scaled up its programme for antiretroviral therapy (ART). There is high potential for the emergence of HIV drug resistance (HIVDR), with an increasing number of patients on ART. It is not feasible to perform testing for HIVDR using laboratory genotyping, owing to economic constraints. This study piloted World Health Organization (WHO) early-warning indicators (EWIs) for HIVDR, and quality-of-care indicators (QCIs), in four ART clinics in Pune city. METHODS: A retrospective study was conducted in 2015, among four ART clinics in Pune city, India. The data on four standardized EWIs (EWI 1: On-time pill pick-up, EWI 2: Retention of patients in ART care at 12 months after initiation, EWI 3: Pharmacy stock-out, EWI 4: Pharmacy dispensing practices) and three QCIs (QCI 1: Regularity in CD4 testing in patients taking ART, QCI 2: Percentage of patients initiating ART within 30 days of medical eligibility, QCI 3: Percentage of patients initiating ART within 30 days of initiation of anti-tuberculosis therapy) were abstracted into WHO Excel HIV data abstractor tools, from the patient records from April 2013 to March 2014. RESULTS: All four ART clinics met the EWI 4 target (100%) for ART dispensing practices. The target for EWIs on-time pill-pick (EWI 1 >90%) and pharmacy stock-outs (EWI 3: no stock-outs, 100%) were achieved in one clinic. None of the clinics met the EWI 2 target for retention in care at 12 months (>90%) and the overall retention was 76% (95% confidence interval: 73% to 79%). The targets for QCI 1 and QCI 2 (>90% each) were achieved in one and two clinics respectively. None of the clinics achieved the target for QCI 3 (>90%). CONCLUSION: ART dispensing practices (EWI 4) were excellent in all clinics. Efforts are required to strengthen retention in care and timely pill pick-up and ensure continuity of clinic-level drug supply among the programme clinics in Pune city. The clinics should focus on regularity in testing CD4 count and timely initiation of ART.